A Phase III Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer
Considering participating in a START clinical trial?
Study Summary
The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).
The primary objective of this trial is to determine whether treatment with pasritamig and docetaxel prolongs radiographic progression-free survival (rPFS) compared with docetaxel alone in participants with metastatic castrate-resistant prostate cancer (mCRPC) who have progressed on at least one androgen receptor pathway inhibition (ARPI).
The key secondary objective for this trial is to demonstrate additional clinical benefit for participants with metastatic castrate-resistant prostate cancer (mCRPC) who have progressed on at least one androgen receptor pathway inhibition (ARPI) treated with pasritamig and docetaxel compared with docetaxel alone.
The other secondary objectives are:
1. To further compare the clinical benefit of combination pasritamig and docetaxel to docetaxel alone.
2. To characterise the safety profile of pasritamig and docetaxel.
3. To evaluate the effect of treatment of pasritamig and docetaxel on Health-Related Quality of life (HRQoL) and participant experience.
The exploratory objectives for this trial are:
1. To assess the pharmacokinetic(s) (PK) and immunogenicity of pasritamig.
2. To investigate biomarkers predictive of clinical response or resistance to pasritamig.
cfda:
The primary objective was to determine, in patients with metastatic castration-resistant prostate cancer (mCRPC), whether pastriag plus docetaxel could prolong radiographic progression-free survival (rPFS) compared to docetaxel . rPFS was defined as the time from the start of treatment to radiographic progression of the disease.
- * Have histologically confirmed adenocarcinoma of the prostate * Have disease that is metastatic at the time of the screening as determined by the investigator * Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (<=) 50 nanogram per milliliter (ng/dL) (<= 1.73 nanomoles per Liter [nmol/L]) at screening * Have progressed on at least 1 novel androgen receptor pathway inhibition (ARPI) but received no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
- Per ISRCTN:
- 1. Be 18 years of age or older at the time of informed consent.
- 2. Have histologically confirmed adenocarcinoma of the prostate.
- 3. Have disease that is metastatic at the time of the screening as determined by the investigator.
- 4. Have progressive disease (defined as per the trial protocol)
- 5. Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analogue (agonist or antagonist) throughout the Treatment Phase or have had prior bilateral orchiectomy and have serum testosterone lower than or equal to50 ng/dL at screening.
- 6. Have progressed on at least one novel androgen receptor pathway inhibition (ARPI) treatment but received no more than two different ARPI for any stage of disease. Must have discontinued ARPI before randomisation into the study.
- 7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- 8. Have an estimated glomerular filtration rate (eGFR) of more than 30 mL/min during the screening period. Participants with obstructive uropathy should have treatment prior to randomisation (e.g., foley catheter, nephrostomy tubes, etc).
- 9. Have the protocol specified laboratory values for hepatic function during the screening period.
- 10. Have the protocol specified hematologic laboratory values during the screening period.
- 13. Agree (while on study treatment and for 6 months after the last dose of study treatment) to not donate gametes (i.e., sperm) or freeze for future use for the purposes of assisted reproduction, and to wear an external condom when transmission of sperm/ejaculate can occur. If able to produce sperm and their partner is of childbearing potential, the partner must practice a highly effective method of contraception.
- 14. Participant (or their legally designated representative) must sign an informed consent form.
- 15. Be willing and able to adhere to the lifestyle restrictions specified in this protocol.
- cfda:
- 1The informed consent form must be signed by someone who is 18 years of age or older, or who has reached the legal age of majority in the region where the study is conducted.2Histological diagnosis confirmed prostate adenocarcinoma3Patients with metastatic disease at the time of screening, and confirmed by the researchers.4Subjects must receive continuous GnRH (gonadotropin-releasing hormone) analog (agonist or antagonist) ADT (androgen deprivation therapy) throughout the treatment period, or have previously undergone bilateral orchiectomy, and have serum testosterone ≤50 ng/dL (≤1.73 nmol/L) at screening.5For any stage of disease, progression must occur while receiving at least one novel ARPI (androgen receptor pathway inhibitor), but no more than two different ARPIs (e.g., abiraterone acetate, apatamide, enzalutamide, dalotamide) must be used. ARPIs must be discontinued before randomization to the study.6ECOG (Eastern Cooperative Oncology Group) performance status score is 0 to 1.
- Known history of either brain or leptomeningeal prostate cancer metastases * Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated * Prior or concurrent second malignancy (other than the disease under study) because the natural history or treatment could interfere with study endpoints * Received cytotoxic chemotherapy for prostate cancer in any setting * Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
- Per ISRCTN:
- 1. Known history of either brain or leptomeningeal prostate cancer metastases.
- 2. Patients with known BReast CAncer gene (BRCA) 1/2 mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated.
- 3. Suspected or known allergies, hypersensitivity, or intolerance to pasritamig or docetaxel excipients.
- 4. Not recovered from recent surgery.
- 5. Solid organ or bone marrow transplantation.
- 6. Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications.
- 7. Any of the protocol specified cardiac conditions within 6 months prior to first dose of study treatment.
- 8. Prior or concurrent second malignancy (other than the disease under study) because the natural history or treatment could interfere with study endpoints.
- 9. Received cytotoxic chemotherapy for prostate cancer in any setting.
- 10. Received prior treatment with human kallikrein 2 (KLK-2) -directed therapies.
- 11. Received prior treatment for prostate cancer with any protocol specified therapies.
- 12. Participants who are HIV-positive and meet any of the protocol specified criteria.
- 13. Active hepatitis of infectious origin.
- 14. Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment. Non-live and non-replication-competent vaccines are allowed.
- 15. Received systemic glucocorticoids (doses greater than 10 mg/day prednisone or equivalent) within 3 days prior to the first dose of study treatment. A single course of glucocorticoids is permitted as prophylaxis for imaging contrast. If glucocorticoids were used to treat immune-related adverse events associated with prior therapy, at least 7 or more days must have elapsed since the last dose of corticosteroid
- 16. Received external beam radiation therapy within 14 days prior to start of study treatment. However, if palliative focal radiation was used, the participant is eligible regardless of date of radiation.
- 17. Any condition which, in the opinion of the investigator, would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- CFDA:
- 1Known history of prostate cancer metastasis to the brain or pia mater2Known BRCA 1/2 (breast cancer gene 1/2) mutations (germline or somatic) and no prior PARP inhibitor therapy, unless PARP inhibitors are unavailable or there are contraindications.3Patients with a history of or concurrent secondary malignancy (excluding the study disease) are excluded because their natural history or treatment may interfere with the study endpoint.4Has received cytotoxic chemotherapy for prostate cancer in any treatment context.5Previous KLK-2 (kallikrein 2) targeted therapy
Clinical Study Information for Healthcare Providers
By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.